Kelly Toth Email & Phone Number

Self-Employed

Kansas City

The SRS is the intermediary between a study’s performance and its reporting. The SRS identifies quality issues related to study conduct at the site and ensure these issues are escalated to the appropriate parties. This helps maintain a well conducted study and thereby contributes to sponsor satisfaction. Manages an 8-protocol program of Site Visit Reports (SVRs) to ensure compliance to the protocol, processes, timelines, SOPs, and GCP guidelines. Oversees 6 global home-based SRS and Associate SRS staff to ensure a comprehensive review of the selection, initiation, interim, and closure visit reports Develops visit report annotations, guidelines and tools in collaboration with Clinical Project Managers (CPMs) Manages the project team compliance to SOPs for submission and approval of the visit reports Identifies and escalates issues and trends noted that could impact subject safety, regulatory compliance or data integrity to the CPM team Confirms documentation and implementation of audits, non-compliance corrective action plans or focused site visit observations requiring corrective /preventative action plans in SVRs Leads scheduled teleconferences with CPMs to discuss SVR trends and study updates Guides project team members to decrease the level of corrections needed on reports by providing mentoring and training on the SVR annotations, SOPs, and GCP guidelines Provides additional SVR support through quality checks, providing back up support and mentoring of junior SRSs

Provided nursing care in a Medical-Surgical environmentVerified medical records to ensure proper care of patients with multiple health-related problems Attended team conferences to discuss issues related to patient care